Sr Quality Assurance Engineer (Onsite - Acton, MA)
Core
Ensuring quality, compliance, and continuous improvement in the manufacturing of Insulet's Omnipod medical devices, supporting new product introductions and process validation.
Role type
Senior Quality Assurance Engineer (Medical Devices)
Builds
High-volume medical device manufacturing processes and quality systems
Domain
Medical Devices / Manufacturing / Quality Engineering
Required skills
Risk management (pFMEA), Process validation, Root cause analysis, Statistical process control, FDA regulations compliance, ISO 13485 knowledge, High-volume manufacturing experience
Preferred skills
Master's degree in engineering, Experience with automated manufacturing equipment, Experience with ISO 14971
Technologies
pFMEA, Statistical process control, Test Method Validation, gauge R&R
Responsibilities
Create and execute new product introduction quality deliverables, Maintain pFMEA for risk management, Review and approve process validation documentation, Support manufacturing process development and qualification, Drive resolution of quality issues using systematic problem solving, Collaborate globally to rollout process improvements
Seniority
Senior, hands-on IC